Medical Device Regulatory Affairs Specialist

Our client is a large producer of class two and three medical devices. They are in need of a Regulatory Affairs Specialist who will be preparing Assurance Cases and 510K submissions.

Principle Duties and Responsibilities:

The consultant will be a Regulatory Affairs Specialist from the medical device industry. They will be tasked with preparing/dealing with Assurance Cases for 510K submissions, dealing directly with Hazard Analysis Files . They must have experience with both Assurance Cases and 510K submissions to be qualified for the role. Ideally this consultant has a background with Infusion pumps and has dealt with submissions related to those types of devices. They must be able to work independently, as well as with a team of other consultants to get a submission done.